Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab
Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will
effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and
LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high
intensity statin therapy and only able to tolerate low potency statin or low weekly dose of
high potency statin and have LDL-C ≥70 mg/dl; (b) initiate alirocumab at 150mg subcutaneously
injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6 and 12 months;
(d) perform quantitative analysis for vascular inflammation and plaque LRNC volume and other
plaque characteristics; (e) compare vascular inflammation and LRNC volume between pre- and
post-alirocumab at 3, 6 and 12 months.
Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a),
non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we
will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at
baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels
between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with changes
atherosclerotic plaque characteristics.
Phase:
Phase 4
Details
Lead Sponsor:
Westside Medical Associates of Los Angeles
Collaborators:
Regeneron Pharmaceuticals University of Washington